Safety Blood Collection Needle (Without Needle Holder)
FDA 510(k) K222141 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
510(k) numberK222141
Submission
- Device name
- Safety Blood Collection Needle (Without Needle Holder)
- Applicant
- Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Anqing City, CN - Received
- July 20, 2022
- Decision date
- October 21, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JKA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252899 | Female Culture Device; Male Culture Device; Transfer Device; Access DeviceJKA · Traditional | Zhejiang Kindly Medical Device Co., Ltd. | 06/02/2026SE |
| K260128 | BD Preset and BD A-Line Arterial Blood Collection SyringesJKA · Special | Becton, Dickinson and Company | 04/15/2026SE |
| K252506 | BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood…JKA · Traditional | Becton, Dickinson and Company | 04/10/2026SE |
| K252378 | BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood…JKA · Traditional | Becton, Dickinson and Company | 04/10/2026SE |
| K252040 | BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood…JKA · Traditional | Becton, Dickinson and Company | 03/13/2026SE |
| K251812 | Steripath® Flow Blood Collection SystemJKA · Traditional | Magnolia Medical Technologies | 09/25/2025SE |
| K243207 | BD Vacutainer® Eclipse Blood Collection NeedleJKA · Traditional | Becton, Dickinson and Company | 07/03/2025SE |
| K250961 | Blood collection tube holdersJKA · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 06/04/2025SE |
| K244047 | Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)JKA · Traditional | Venocare, Inc. | 05/23/2025SE |
| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection SetJKA · Special | Sol-Millennium Medical, Inc. | 04/30/2025SE |
More from Sol-Millennium Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K234024 | HWJECT Auto-disable syringeFMF · Traditional | 03/19/2024SE |
| K230061 | Insulin SyringeFMF · Traditional | 11/30/2023SE |
| K230043 | Insulin Pen NeedleFMI · Traditional | 09/20/2023SE |
| K223323 | Blood Collection Needle (with/without Needle Holder)JKA · Traditional | 03/24/2023SE |
| K222124 | Sterile Hypodermic Syringe with/without Needle, Hypodermic NeedleFMI · Traditional | 11/04/2022SE |
| K220900 | Safety Blood Collection Needles with/without Needle HolderJKA · Traditional | 08/10/2022SE |
| K220083 | LDV((Low Dead Volume )SyringeQNQ · Traditional | 05/25/2022SE |
| K214075 | Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection /…FMI · Traditional | 04/12/2022SE |
| K211555 | Hypodermic Safety Needle; Hypodermic Safety Needle with SyringeMEG · Traditional | 10/18/2021SE |
| K202188 | Safety Blood Collection Sets for Single UseJKA · Traditional | 02/19/2021SE |
Questions and answers
When was Safety Blood Collection Needle (Without Needle Holder) cleared by the FDA?
Safety Blood Collection Needle (Without Needle Holder) (K222141) received a 510(k) decision of Substantially Equivalent on October 21, 2022, 93 days after the submission was received.
What is the product code of K222141?
The FDA product code is JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection, a Class II (moderate risk) device regulated under 21 CFR 862.1675.